High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
- Conditions
- Congenital Heart Disease
- Interventions
- Procedure: Ultrafiltration
- Registration Number
- NCT04920643
- Lead Sponsor
- IWK Health Centre
- Brief Summary
Malformations of the heart are common; 1.35 million infants are born each year with congenital heart disease. Many of these defects carry a considerable threat to the individual's quality of life as well as survival. Along with focused medical management, surgical repair remains a standard of care for more than 25,000 infants and children each year in the United States and Canada. The care of individuals with congenital heart disease is highly complex and has significant risks of morbidity and mortality. Most cardiac operations require the use of cardiopulmonary bypass (CPB, also known as the heart-lung machine) to safely access the inner chambers of the heart. CPB itself has been well documented to cause significant inflammation and hemodilution as the individual's blood is passed through a foreign circuit. This inflammatory response can lead to fluid overload, distributive shock and potential end-organ dysfunction in the heart, lungs, kidneys, brain, liver or bowels. These organ dysfunctions may culminate in post-operative low cardiac output syndrome (LCOS), prolonged ventilation time, prolonged intensive care unit (ICU) stay and can contribute to mortality.
Dampening the inflammatory response from CPB has been a focus of research interest for years. Intra-operative ultrafiltration has been used to remove excess fluids and filter off inflammatory cytokines during cardiac operations. Over 90% of children's heart centers in the world utilize some form of ultrafiltration (mostly some form of modified ultrafiltration), but there are wide variations in published ultrafiltration protocols (none of which are combination SBUF-SMUF in children). Ultimately, this project seeks to provide high-quality evidence that the immunologic and clinical effects of combination SBUF-SMUF are rate dependent. Therefore, a randomized study directly comparing a high-exchange SBUF-SMUF (60ml/kg/hr) and a low-exchange SBUF-SMUF (6ml/kg/hr) can identify which is the optimal ultrafiltration protocol to enhance post-operative clinical outcomes for this patient population. The expected data and results could be immediately applicable to improve recovery after heart surgery for infants and children across Canada and the rest of the world at large.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- Congenital heart patients (2.5 - 15kg) have consented for a planned cardiac surgery procedure requiring cardiopulmonary bypass.
- Parent or legal substitute decision-maker informed written consent to participate in the study.
- Patient or family refusal to participate.
- Patient over 15kg (Fontan or Glenn patients will be considered up to 18kg)
- No planned use of cardiopulmonary bypass
- Isolated ASD repair
- Known severe hematologic abnormality such as sick cell anemia, thalassemia, haemophilia A or B, von Willebrand disease or other.
- Known genetic syndrome with severe neurologic or multi-organ abnormalities and immune dysfunction such as DiGeorge Syndrome, Trisomy 18 or 13, Noonan syndrome. (Trisomy 21 may be included in the study).
- Known immunodeficiency syndrome or bone marrow pathology.
- Severe liver or renal disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low-Exchange Ultrafiltration Ultrafiltration Subzero-Balance Simple Modified Ultrafiltration (6ml/kg/hour) High-Exchange Ultrafiltration Ultrafiltration Subzero-Balance Simple Modified Ultrafiltration (60ml/kg/hour)
- Primary Outcome Measures
Name Time Method Peak Vasoactive-Ventilation Renal Score Up to 5 days
- Secondary Outcome Measures
Name Time Method Inotrope Time Up to 28 days Peak Oxygenation Index Up to 5 days Ventilation Index Up to 5 days Taken in time series at ICU admission, 0, 12, 24, 36, 48, 72, 96 and 120 hours.
Ventilator Free Days Up to 28 days Low Cardiac Output Syndrome Up to 3 days Defined by any one of the following within the first 72 post-operative hours:
* Lactate \> 4mM with oxygen extraction \>35% (SaO2 - ScvO2/ SaO2)
* VIS \> 15.0 with oxygen extraction \>35% (SaO2 - ScvO2/ SaO2)
* Mechanical circulatory support requirementVasoplegic Shock Up to 3 days Defined by any one of the following with the first 72 post-operative hours:
* Lactate \> 4mM with oxygen extraction \<25% (SaO2 - ScvO2/ SaO2)
* VIS \> 15.0 with oxygen extraction \<25% (SaO2 - ScvO2/ SaO2)C-Reactive Protein Concentrations Measured at 1 day Vasoactive Inotrope Score Up to 5 days Taken in time series at ICU admission, 0, 12, 24, 36, 48, 72, 96 and 120 hours.
Ventilation Time Up to 28 days Vasoactive-Ventilation Renal Score Up to 5 days Taken in time series at ICU admission, 12, 24, 36, 48, 72, 96 and 120 hours.
Oxygenation Index Up to 5 days Taken in time series at ICU admission, 0, 12, 24, 36, 48, 72, 96 and 120 hours.
Inotrope Free Days Up to 28 days Cytokine Concentration (Patient Plasma) Up to 1 day C3, C3a, C3b, C5, C5a, IL-1, IL1-Ra, IL-6, IL-10, TNF, CXCL-8 among others. The final selection of mediators will be subject to final pilot study results and assay availability. Taken at baseline, 0 hours and 24 hours after CPB.
Lactate Up to 5 days Measured by arterial blood gas (mM)
Creatinine Up to 5 days Blood Concentration (uM)
Inotrope Dependence Up to 2 days Vasoactive-inotrope score at 48 hours equal to or greater than that at ICU admission.
Loop Diuretic Use Up to 7 days Total loop diuretic (mg/kg), measured in furosemide equivalents, during the first 7 post-operative days.
Peak Ventilation Index Up to 5 days Haptoglobin (Plasma) Up to 1 day Complete blood count Up to 5 days Composite Outcome of mechanical circulatory support, acute renal failure, prolonged intubation and operative mortality. Up to 30 days Acute Kidney Injury Up to 28 days KDIGO Criteria
Peak Vasoactive-Inotrope Score Up to 5 days Prolonged Intubation Up to 28 days Mechanical ventilation for more than 7 days
ICU Length of Stay Up to 30 days Hospital Length of Stay Up to 60 days
Trial Locations
- Locations (1)
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada